Warning letter
Sea-Long Medical Systems, LLC: warning letter of Apr 4, 2023
FDA warning letter 647320 · Division of Medical Device and Radiological Health Operations West
Key facts
| Reference number | 647320 |
|---|---|
| Company | Sea-Long Medical Systems, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Apr 4, 2023 |
| Posted date | May 16, 2023 |
| Issuing office | Division of Medical Device and Radiological Health Operations West |
| Product type | Devices |
| CFR sections cited | 801, 801.3, 830, 830.3, 868.5470, 801.40(a)(1), 801.40(a)(2), 801.20(a), 830.300(a), 820, 807.81(b) |
| Inspection city | Waxahachie |
| Inspection ZIP | 75167 |
| Inspection start date | Aug 22, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: